JENNIFER SUND

• Created Process Validation deliverables (such as validation plan and protocol, process control strategy) for a new manufacturing line for a device/drug product (autoinjector).

• Provided Device Quality oversight for the development, review and/or approval of Device Design History File (DHF) deliverables.

• Provided Device Quality oversight for a combination product (on-body delivery system)
• Provided internal and external Device Quality oversight for the development and/or review and approval of Design History File (DHF) deliverables resulting in a successful launch of combination product
• Evaluated external supplier Design Changes for impact to the Combination Product and/or Device DHF to ensure the change identified all the impacted deliverables
• Reviewed supplier timelines to ensure alignment with the internal project timelines
• Guided team in documenting nonconformances/unplanned deviations and corrective actions/preventive actions (CAPA)
• Collaborated with the team to create escalation presentation for management
• Reviewed and approved supplier planned deviations and nonconformances
• Worked with team to simplify the quality management system (QMS) procedures for Test Method Validation, Test Method Transfer and Device Laboratory Investigations.

⦁ Managed the creation and approval of the quality management system (QMS) manual, procedures, and templates in accordance with FDA Quality System Regulation 21 CFR 820, ISO 13485, and ISO 14971.
⦁ Provided Quality oversight for the development, review and/or approval of Medical Device Design History File (DHF) deliverables.

• Managed Device Quality team that is responsible for new product and sustaining quality for a Class II medical device (blood glucose pump and monitor) and drug delivery devices used for combination products
• Provided Device Quality oversight for new product introduction deliverables, and design and/or process change deliverables (e.g., requirements, plans, protocols, reports, and risk analysis) resulting in a successful launch of a combination device for a large pharmaceutical customer
• Developed new quality management system (QMS) procedures and revised existing QMS procedures ensuring that procedures reflected current practices and met FDA Quality System Regulation 21 CFR 820 and ISO 13485
• Implemented a new Quality Management System tool (MasterControl) for the Lot Acceptance testing
• Design Control Subject Matter Expert responsible for direct interaction with FDA, notified body, and internal auditors
• Created and implemented corrective and preventive action plans (CAPAs) for products and processes.

• Provided Device Quality oversight for a Class II medical device (patient monitor), and custom test tools (software, electrical and mechanical)
• Developed new quality management system (QMS) procedures and revised existing QS procedures ensuring that each procedure reflected current practice and met FDA Quality System Regulation 21 CFR 820, ISO 13485, and ISO 14971
• Member of the Global Risk Management team
• Guided team in the creation of product software and hardware deliverables (Design Input through Design Validation), and validation of non-product software and custom test tools
• Audited the design history file for completeness
• Guided team in the transfer of a manufacturing site resulting in zero observations during a notified body audit
• Guided team in failure/root cause analysis of field issues
• Created field issue spreadsheet to analyze field failure data for field trends

• Managed the creation and approval of quality management system (QMS) procedures and associated templates (e.g., Design Control, Risk Management and Document Control) in accordance with FDA Quality System Regulation 21 CFR 820, ISO 13485, and ISO 14971.